LUCEA 40

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. EVENT SITE NAME: (B)(6)GENERAL. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

THE CORRECTION OF B3 DATE OF EVENT, B5 DESCRIBE EVENT AND PROBLEM, H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE -EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 28TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 21ST MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. PREVIOUS B3 DATE OF EVENT: 03/28/2023. CORRECTED B3 DATE OF EVENT: BLANK. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER?: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER?: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE -EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE -EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. BASED ON AN INFORMATION GATHERED, DEFECTIVE PARTS (HANDLE INTERFACE WITH FORK - LUCEA 40 - ARD368605998 AND TRANSPARENT PLASTIC COVER - LUCEA 40 - ARD368606555) WERE REPLACED. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. THE ANALYSIS IS FOLLOWING: THE CLEANING AND HANDLING TESTS CRE 12-085 PERFORMED BY GETINGE DID NOT LEAD TO CRACKS. BASED ON THIS TEST, THE MOST PROBABLE CAUSES LEADING TO THE HANDLE INTERFACE CRACKS IS AN IMPROPER USES AND COLLISIONS. TO PREVENT ANY INCIDENT THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS: TO CHECK THAT THE DEVICE HAS NOT SUFFERED ANY IMPACT DAMAGE. TO CHECK FOR ANY CHIPPED OR MISSING PAINT. ALSO THE FOLLOWING WARNING IS MENTIONNED IN THE IFU: WARNING! RISK OF INJURY/INFECTION. THE USE OF A DAMAGED DEVICE MAY LEAD TO A RISK OF INJURY FOR USERS OR A RISK OF INFECTION FOR PATIENTS. DO NOT USE A DAMAGED DEVICE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

ON 21TH MARCH 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HEADLIGHT COVER WAS BROKEN RESULTING IN MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.